The present invention relates to alcohol concentration assay test systems, including compositions and methods for storing multiple alcohol concentration assay tests and compositions and methods for measuring the concentration of alcohol in a sample.
Automobile crashes caused by individuals who are impaired by alcohol are a significant social and economic problem. Many individuals, some of whom may have had only a few drinks, drive impaired because they physically feel fine. Many of these drivers-do not know that their bodies have absorbed enough alcohol to increase their risk of getting into a crash.
If impaired individuals had an easy and safe way to check how much alcohol their bodies had absorbed prior to operating a motor vehicle instead of relying on how they physically felt, many would change their decision to drive and crashes would be prevented. There is much need for an assay test that would allow impaired individuals to check their alcohol concentration and determine their capacity to safely operate a motor vehicle.
There are many devices that test individuals"" alcohol concentration that are available in the marketplace today. However, many of these devices are too complex or expensive for use by individuals outside of a laboratory or clinical setting. Additionally, many individuals have an aversion to blood and urine testing and would not be willing to self-administer such assay tests. Inexpensive breath assay tests are available as a less invasive alternative to blood and urine based assay tests. However, inexpensive breath assay tests are much less accurate than blood-based assay tests, the standard for which all alcohol assay tests are compared, and many are difficult to use. Saliva alcohol concentration assay tests, which exhibit a strong, direct correlation to blood alcohol concentration assay tests, are an inexpensive and less invasive alternative to blood and urine-based assay tests and some are proven to be accurate. However, saliva assay tests that adequately combine ease of use, small size, speed, accuracy, low cost, durability (e.g., temperature stability and shelf life), safety and interpretability, and that are designed for widespread distribution and use are not available. Furthermore, delivery systems for packaging, storing, carrying, preserving, and otherwise maintaining alcohol tests are not available so as to provide adequate ease of use, discrete use, accessibility, and durability of tests. This is readily apparent from the lack of widespread use of such tests. Although some assay tests meet some of the desired characteristics, no assay test meets enough of the criteria to facilitate widespread use for self-detection of alcohol concentration.
The present invention relates to alcohol concentration assay test systems, including compositions and methods for storing multiple alcohol concentration assay tests and compositions and methods for measuring the concentration of alcohol in a sample (e.g., a biological sample).
For example, the present invention provides a system comprising an assay for analyzing a sample for the presence of ethanol, said system comprising one or more alcohol concentration assay tests, a delivery system, and a desiccant. In preferred embodiments, the desiccant is provided as a desiccant entrained polymer storage container. However, in some embodiments, the desiccant is provided on or in the test assay itself. In some embodiments, the delivery systems contains a plurality of alcohol concentration assays tests (e.g., 2, 3, 4, 5, . . . 100, . . . ). In some preferred embodiments, the alcohol concentration assays tests comprises test strips. While the test strips are not limited to any particular size, in preferred embodiments, the test strips have a thickness of 0.5 millimeters or less, a length of 6.5 centimeters or less, and a width of 5 millimeters or less. In preferred embodiments, the alcohol concentration assays tests are stable in the desiccant entrained polymer storage container for at least one month, preferably for at least six months, more preferably for at least one year, and most preferably for at least two years.
In some embodiments of the present invention, assay tests are provided for the detection of any analyte from any sample type, wherein the assay test contains a desiccant (e.g., an entrained desiccant) directly associated with the assay test. This is in contrast to available systems where desiccants are provided in storage containers. In these embodiments of the present invention the desiccant is provided on the assay test so that the assay test provides its own desiccation, regardless of the environment it is in (e.g., regardless of whether it is in a container containing a desiccant). The desiccant is associated with the test assay using any suitable means and in any configuration. For example, where the test assay comprises a test strip, the desiccant can be provided on or in the material comprising the strip portion of the test strip or on or in the handle portion. The desiccant containing assay tests are amenable to movement from one container to another. The desiccant containing assay tests may be stored in any type of container, regardless of whether the containers contain a desiccant or not (e.g., the assay tests may be stored in foil or polymer protective enclosure with or without desiccant materials in the enclosure).
In some embodiments, the desiccant entrained storage container further comprises one or more protective storage compartments capable of enclosing one or more alcohol concentration assay tests in each of the one or more compartments. In further embodiments, the container comprises a cap connected to the container by a hinge wherein the lid can be closed to form an air tight seal. While the container can be of any desired size, in preferred embodiments, the container has a thickness of 5 millimeters or less (preferrably 2-3 millimeters or less), a height of 8 cm or less (preferrably 5 cm or less), and a diameter of 5 cm or less (preferrably 2.5 cm or less). The delivery system may also be of any desired shape including, but not limited to, circular, oval, and polygonal (e.g., trigonal, pentagonal, hexagonal, etc.).
In some embodiments, the desiccant entrained storage container is made of functional polymers comprising an anhydride, an amine, an acid, a cyanate, an isocyanate, or an hydroxy functionalized polymer. In preferred embodiments, the polymer comprises propylene maleic anhydride, polyethylene maleic anhydride (anydride), polyethylene acrylic acid, polyethylene-urethane, polyethylene-EVOH, polyethylene nylon, or polyamide. In some preferred embodiments, the polymer comprises a channeling agent. In some embodiments, the channeling agent comprises a polar compound having one or more hydroxy groups. In particularly preferred embodiments, the channeling agent comprises polyethylene glycol, polypropylene glycol, ethylene vinyl alcohol, polyvinyl alcohol, or glycerin.
In some embodiments, the delivery system does not contain a desiccant. For example, in some embodiments the alcohol tests are stored in a sealed, air-tight container in a low moisture environment (e.g., in a sealed flat foil container). In some embodiments, the desiccant is provided on the assay tests themselves. In some embodiments the desiccant is not entrained.
The present invention also provides a system comprising a plurality of test assays for analyzing a sample for the presence of ethanol, the system comprising a plurality of alcohol concentration assay tests within a delivery system, said delivery system preventing the alcohol concentration assay tests from being exposed to the environment wherein the delivery system is configured to dispense the plurality of alcohol concentration assay tests individually (e.g., one at a time). In some embodiments, the delivery system is configured to dispense the plurality of alcohol concentration assay tests individually without exposing the remaining alcohol concentration assay tests (i.e. the tests that have not yet been dispensed) to the environment. In preferred embodiments, the delivery system comprises a desiccant entrained polymer storage container.
The present invention further provides a system comprising a diagnostic device for analyzing saliva for the presence, of ethanol, with the diagnostic device comprising: a solid support; one or more collection sites attached to a first portion of the solid support, wherein the collection site is capable of collecting a saliva sample; one or more reaction means attached to a second portion of the solid support, wherein the reaction means produces a detectable signal in the presence of ethanol; wherein the solid support, collection site, and reaction means are contained within a single device. In some embodiments, no solid support is provided (i.e., the test is made of only a collection site and reaction means). In some embodiments, the collection site and reaction means may be in contact with one another (e.g., an absorbent material layered onto or integrated with a reaction means). Thus, in some embodiments the first portion and second portion of the solid support may define partially or entirely overlapping regions of the solid support. In some embodiments of the present invention, multiple collection sites and multiple reactions means are used. The plurality of collections sites find use, for example, in detecting different threshold concentrations of alcohol (e.g., a first collection site that detects 0.4% and a second collection site-that detects 0.8%), different detectable readouts,(e.g., different colors or a first collection site that shows a color and a second collection site that produces a symbol, shape, or word), different read-out formats (e.g., a first collection site that uses an on/off readout and a second collection site that uses a gradient readout), different detection purposes (e.g., detection versus indicator [to test if the assay is working properly] or detection of different analytes) and the like
In some embodiments of the present invention, the diagnostic device comprises a thickness, a width, and a length, wherein the thickness is 1.5 millimeters or less, the length is 5 centimeters or less, and the width is 1.25 centimeters or less, although larger and smaller dimensions are also contemplated by the present invention. In other embodiments, the solid support comprises plastic. In yet other embodiments, the collection site comprises an absorbent material.
In some preferred embodiments, the reaction means comprises one or more alcohol metabolizing enzymes. In other preferred embodiments, the reaction means comprises a biosensor. In some embodiments, the reaction means further comprises one or more competitors, wherein the one or more competitors are capable of preventing the reaction means from producing the detectable signal until the one or more competitors are substantially depleted or otherwise prevent the detectable signal from being substantially detectable unless a threshold concentration of alcohol is present in a sample (e.g., no substantially detectable signal unless a sample contains an alcohol concentration corresponding to a blood alcohol concentration of 0.04%). It is contemplated that, in some embodiments, multiple competitors are used, each with a different threshold level, such that the reaction means produce detectable signals at two or more particular concentrations of test samples. However, it should be noted that, in some embodiments, multiple threshold levels are obtained with the use of a single competitor or no competitors. Indeed, any desired detection configuration can be used. For example, a first detection event may occur at a desired threshold level of alcohol, followed by a gradient detection read-out above the threshold level (e.g., a first detected color is observed above a concentration of 0.04%, followed by a gradual increase in a color from concentrations above 0.04%). In some embodiments, the reaction further comprises one or more stabilizers (e.g., compounds that increase the shelf-life of the reaction means in response to moisture, light [e.g., ultra-violet light], air, and the like). In yet other embodiments, the reaction means comprises two or more reaction components, wherein the two or more reaction components of the reaction means are separated by one or more breakable barriers. In some embodiments, the reaction means is enclosed in a protective encasement.
In some embodiments of the present invention, the first and second portions of the solid support are separated by a hinge. In other embodiments, the first and second portions of the solid support are separated by a breakable barrier. In yet other embodiments, the collection site is slidingly attached to the solid support.
In some preferred embodiments, the system further comprises a protective encasement, wherein the diagnostic device is enclosed in the protective encasement.
In some preferred embodiments of the present invention, the diagnostic device further comprises a second reaction means attached to a third portion of the solid support, wherein the second reaction means produces a second detectable signal, with the second detectable signal indicating a sufficient volume of the test sample (e.g., saliva sample).
In some embodiments of the present invention, the alcohol detection test assay comprises a xe2x80x9ctest stripxe2x80x9d with a thickness, a width, and a length, wherein the thickness is 0.5 millimeters or less, the length is 6.5 centimeters or less, and the width is 5 millimeters or less, although larger and smaller dimensions are also contemplated by the present invention.
The present invention further provides a system comprising a plurality of test assays for analyzing a sample for the presence of an analyte (i.e., any material to be detected in a sample including, but not limited to, biological materials, organic compounds, drugs, etc.), said system comprising a plurality of assay tests within a delivery system, said delivery system preventing the assay tests from being exposed to the environment and wherein said delivery system comprises a length, a width, and a thickness, wherein said length is 8.5 cm or less, said width is 6.0 cm or less, and said thickness is 2 millimeters or less. In preferred embodiments, the delivery system is configured to dispense the plurality of assay tests individually.
In some embodiments of the present invention, the system further comprises a delivery system, whereby the delivery system comprises one or more compartments capable of storing one or more of the diagnostic devices. In preferred embodiments, the delivery system comprises two or more compartments, each compartment accessible (e.g., independently accessible) to allow use of one or more alcohol concentration tests without exposing tests in other compartments. In some embodiments, the delivery system further comprises one or more protective encasements capable of enclosing the diagnostic devices in the one or more compartments. In yet other embodiments the delivery system further comprising one or more placards.
The present invention also provides a delivery system comprising one or more first packages comprising one or more compartments and a second package containing the one or more first packages. For example, in one embodiment the delivery system comprises one or more alcohol concentration assay tests, two or more first packages comprising one or more compartments, wherein the one or more alcohol concentration assay tests are contained in the first package; and a second package, wherein the two or more first packages are contained in the second package. For example, in some embodiments, the second package comprises a thin folded delivery system. In some embodiments, the folded delivery system comprises a single fold, wherein the first package is affixed to or contained in a portion of the delivery system such that, -in folded form, the first package is enclosed within the folded delivery system. In yet other embodiments, the folded delivery system comprises a pocket, wherein the first package is contained within the pocket. In other embodiments, the folded delivery system comprises two or more folds. For example, in some embodiments, the folded delivery system comprises two folds to provide a three-panel container.
In a particularly preferred embodiment, alcohol concentration tests are contained in first packages wherein the first packages comprise a first wall and a second wall and wherein each wall comprises at least one layer. In some embodiments, multiple layers are provided. In some embodiments three layers are provided where the inner-most layer comprises an interior heat-sealed protective layer (e.g., a plastic layer), a intermediate xe2x80x9cbarrierxe2x80x9d layer (e.g., a foil, polymer, or polymer film [SARAN, BARAX] layer), and an outer layer (e.g., a paper, carboard, or polymer layer). In some embodiments, four layers are provided. For example, in some embodiments a xe2x80x9ctiexe2x80x9d layer is provided between the barrier layer and outer layer (e.g., a plastic or polymer [polyethylene] layer). The first and second wall are connected at the edges to form an interior opening in which the alcohol concentration test is enclosed (e.g., sealed). In some embodiments, the outer surface of each wall further comprises diagrams, text, or other written materials (e.g., instructions, warning, logo, etc.). In some embodiments, the first packages are contained in second packages. In preferred embodiments, the second package is approximately the size and shape of a credit card. In one preferred embodiment, the second package is made of a first, wall and a second wall, wherein the second wall is sealed to the first wall along three edges, forming an opening on one end of the second package. The first packages are insertable and removable through the opening. In particularly preferred embodiments, the first wall of the second package is transparent to allow visibility of the contents (e.g., visibility of written materials on the first packages contained within the second package). In other preferred embodiments, the second package is made of plastic. In yet other preferred embodiments, the second package contains two or more first packages (e.g., to allow users to access alcohol concentration tests on more than one occasion).
In other embodiments, the second package comprises a first and second wall connected by a hinge along one edge of the first and second walls. Alcohol concentration tests are attached to the inner surface of the first wall (e.g., enclosed in a pouch contained on the inner surface of the first wall). When the hinge is closed, the alcohol concentration tests are enclosed between the first and second walls. When the hinge is opened, the alcohol concentration tests are accessible.
In yet another preferred embodiment, the delivery system further comprises a flat solid support and one or more first packages (each containing one or more alcohol concentration tests in one or more compartments) attached (e.g., glued) to the flat solid support. In a preferred embodiment, the first packages are attached to the solid support in such a manner that the alcohol concentration tests are accessible without removing the first package(s) from the solid support.
The present invention also provides a delivery system for storing alcohol assay tests, comprising one or more (e.g., two or more) compartments capable of containing alcohol assay tests. In some preferred embodiments, the delivery system further comprises a plurality of protective encasements capable of enclosing the alcohol assay tests in the compartments. In other preferred embodiments, the delivery system comprises a thickness, a width, and a length, wherein the thickness is 2 millimeters or less, the length is 6.0 centimeters or less, and/or the width is 8.5 cm or less. In yet other preferred embodiments, the delivery system has a thickness less than 1 millimeter, a length less than 8.5 centimeters, and/or a width less than 5.6 cm. In yet other preferred embodiments, the delivery system is the approximate size and shape of a standard credit card. In yet other preferred embodiments, the delivery system further comprises one or more placards.
While the present invention is not limited by the materials used in the delivery system, in some preferred embodiments, the delivery system is made of plastic or a paper or cardboard material. In some embodiments, the paper or cardboard material comprises laminated paper or cardboard.
The present invention further provides a delivery system for storing alcohol assay tests, comprising one or more (e.g., two or more) compartments and one or more alcohol assay tests, wherein the one or more alcohol assay tests are contained within the one or more compartments. In preferred embodiments, the delivery system comprises two or more compartments, each containing one or more alcohol concentration tests. In some preferred embodiments, the delivery system further comprises a plurality of protective encasements, wherein the protective encasements enclose the one or more alcohol assay tests in the compartments. In other preferred embodiments, the delivery system comprises a thickness, a width, and a length, wherein the thickness is 2 millimeters or less, the length is 5.5 centimeters or less, and/or the width is 8.25 cm or less. In yet other preferred embodiments, the delivery system has a thickness less than 1 millimeter, a length less than 8.5 centimeters, and/or a width less than 5.5 cm. In yet other preferred embodiments, the delivery system is the approximate size and shape of a standard credit card. In yet other preferred embodiments, the delivery system further comprises one or more placards. In other embodiments, the delivery system comprises plastic.
In some preferred embodiments, the delivery system comprises a protective storage container comprising a round or oval vial with a thickness, a width, and a length. While the present invention is not limited by the dimensions of the container, in preferred embodiments, the thickness is 5 millimeters or less, the length is 5 centimeters or less, and the diameter is 2.5 cm or less. In other embodiments, the delivery system is a round or oval vial made of a thermo-plastic polymer with an entrained desiccant that removes moisture from the interior of the container. In some embodiments of the present invention, the system further comprises a delivery system, whereby the delivery system comprises a protective storage container having one or more compartments capable of storing one or more of the assay tests. In preferred embodiments, the storage container has a cap providing an air tight seal and connected by a hinge of the same said polymer material wherein said cap, hinge and container are molded as one piece. In still more preferred embodiments the storage container is made of a hard thermo-plastic polymer with an entrained desiccant allowing for easy accessibility without jeopardizing the reaction means to environmental moisture or humidity.